Flexor G56230Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00827002562301), received between Dec 1, 2016 and Oct 18, 2019 — classified as 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Material Separation” (5 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 18, 2019Material Separation; Material Separation

  NO ADDITIONAL INFORMATION REGARDING THE PATIENT AND/OR EVENT HAS BEEN RECEIVED SINCE THE PREVIOUS MEDWATCH REPORT WAS SENT.

  Patient problems: No Code Available

  MAUDE report 9208905 ↗
• MalfunctionJul 3, 2019Material Separation; Material Separation

  NO NEW PATIENT OR EVENT INFORMATION SINCE THE LAST REPORT WAS SUBMITTED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8757863 ↗
• MalfunctionAug 30, 2018Material Separation; Material Separation

  IT WAS REPORTED, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH SEPARATED DURING A LEG ANGIOGRAM PROCEDURE INVOLVING A (B)(6) FEMALE PATIENT. ACCESS FOR THE PROCEDURE WAS GAINED VIA A CONTRALATERAL APPROACH. DURING THE REMOVAL ATTEMPT, WHILE TWO OTHER MANUFACTURE'S DEVICES WERE BEING UTILIZED THROUGH THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH, IT SEPARATED. THERE WAS NO TORTUOSITY OR CALCIFICATION NOTED IN PATIENT'S ANATOMY. THE PHYSICIAN REMOVED THE SHEATH WITH NO ISSUES. A SECTION OF THE DEVICE DID NOT REMAIN INSIDE THE PATIENT¿S BODY. THE PATIENT DID NOT REQUIRE ANY ADDITIONAL PROCEDURES DUE TO THIS OCCURRENCE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 7834614 ↗
• MalfunctionJan 23, 2018Material Separation; Failure to Advance; Wrinkled; Material Separation; Failure to Advance; Wrinkled

  IT WAS REPORTED THAT DURING PREPARATION FOR PERIPHERAL INTERVENTION, THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH INNER DILATOR WOULD NOT ADVANCE INTO THE SHEATH. THE DEVICE DID NOT COME INTO CONTACT WITH THE PATIENT. ANOTHER FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS USED TO SUCCESSFULLY COMPLETE THE PROCEDURE. ACCORDING TO THE INITIAL REPORTER, THE PATIENT DID NOT EXPERIENCE ANY ADVERSE EFFECTS DUE TO THIS OCCURRENCE. ON 22DEC2017 DURING INVESTIGATION OF THE COMPLAINT DEVICE, IT WAS OBSERVED THAT THE SHEATH TUBING WAS WRINKLED AND HAD BEGUN TO SEPARATE BELOW THE HUB. THE COILING WAS EXPOSED, AND THE DILATOR SHAFT WAS NOTED TO BE KINKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7213768 ↗
• InjuryMay 11, 2017Difficult to Remove; Difficult to Remove

  IT WAS REPORTED DURING A RIGHT LEG PERCUTANEOUS TRANSLUMINAL ANGIOPLASTY (PTA) PROCEDURE, THERE WAS A COMPLICATION WITH A 5 FRENCH ANSEL HIGH FLEX SHEATH THAT WAS UNABLE TO BE RETRACTED/REMOVED FROM THE PATIENT. IT WAS REPORTED THAT PLANS WERE TO TAKE THE PATIENT TO SURGERY ALTHOUGH THE PATIENT WAS REPORTED TO BE DOING FINE. THE PLAN WAS TO DO A CUT DOWN PROCEDURE OF THE EFFECTED LEG AND REMOVE THE SHEATH DURING SURGERY. IT WAS REPORTED THAT THE VASCULAR SURGEON HAD NOTED WHEN PRESSING ON THE PATIENT'S GROIN AREA, A SIZEABLE CHUNK OF CALCIUM. ON (B)(6) 2017, THE PATIENT UNDERWENT A CUT DOWN PROCEDURE. IT WAS NOTED THAT THE CALCIUM CHUNK WAS HOLDING THE SHEATH. THE SURGEON WAS ABLE TO REMOVE AND RELEASE THE SHEATH BY REMOVING THE CALCIUM. POST PROCEDURE IT WAS NOTED THAT DUE TO THE DURATION OF WAITING TO UNDERGO THE CUT DOWN PROCEDURE, THE LEG HAD THROMBOSED. THE PATIENT WAS PLACED ON ANTIBIOTIC THERAPY. THE PHYSICIAN WILL MONITOR THE PATIENT TO DETERMINE WHEN THE BY-PASS PROCEDURE CAN BE SCHEDULED.

  Patient problems: No Code Available; Thrombus

  MAUDE report 6561746 ↗
• MalfunctionDec 1, 2016Material Separation; Material Separation

  THE FLEXOR HIGH-FLEX ANSEL GUIDING SHEATH WAS ADVANCED AND ANOTHER MANUFACTURER¿S BALLOON WAS USED/INFLATED. A LOT OF RESISTANCE WAS MADE IN ATTEMPTING TO REMOVE THE BALLOON. PER THE DM, ¿THEY PULLED SO HARD, I DID NOT THINK THEY WERE GOING TO GET THE BALLOON OUT.¿ THE PHYSICIAN WAS FINALLY ABLE TO REMOVE THE BALLOON AND SHEATH AND EXCHANGED WITH ANOTHER SMALL NON COOK 4 FR SHEATH. THE WIRE WAS REMOVED THROUGH THE SHEATH AND AT THAT TIME IT WAS NOTED THAT THE LINING FROM THE FIRST SHEATH WAS ENTANGLED WITH THE WIRE. ALL WAS REMOVED FROM THE PATIENT WITH NO ADVERSE EFFECTS.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6137616 ↗